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FDA Approves Kerendia to Treat CKD Associated with Type 2 Diabetes

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FDA Approves Kerendia to Treat CKD Associated with Type 2 Diabetes

The United States Food and Drug Administration (FDA) has approved the Kerendia (finerenone) for the treatment of chronic kidney disease patients associated with type 2 diabetes.

Bayer announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) tablets to reduce the risk of decline in kidney function, kidney failure, cardiac death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes Kerendia (finerenone) tablets are approved.

Diabetes is one of the prominent causes of chronic kidney disease and kidney failure in the United States. Chronic kidney disease occurs when the kidneys become damaged and cannot filter blood normally. Because of faulty filtering, patients may have complications related to fluid, electrolytes (minerals essential for many bodily processes), and waste buildup in the body. Chronic kidney disease can sometimes progress to kidney failure. Patients are also at higher risk of heart disease.

The efficacy of Kerendia for improving kidney and cardiovascular outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type 2 Diabetes. In this study, 5,674 patients were randomly assigned to receive Kerendia or a placebo.

The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint, including at least 40% reduction in kidney function, progression to kidney failure, or kidney death. The results showed that 504 of the 2,833 patients receiving Kerendia had at least one event in the overall endpoint, compared with 600 of the 2,841 patients receiving placebo.

Side effects associated with the Kerendia include hyperkalemia (high levels of potassium), hyponatremia (low levels of sodium), and hypotension (low blood pressure). Patients with adrenal insufficiency (when the body does not produce enough of certain hormones) and those receiving simultaneous treatment with strong CYP3A4 inhibitors should not take Kerendia.

Source: FDA

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